Biotech Values

[AlpineBV_Miller]

Often times, trial was designed/expected conservatively for active arm in a larger trial, assuming worse than result from previous smaller trial, but actual result was trending much closer to previous trial results, thus caused event accural delay.

This is very rarely seen in dev-stage biotech. Often, they underestimate (conservatively) what they saw in a non-randomized P2 trial. This is very common in combo situations. This rarely works out.

This is probably true in most cases. There are cases where positive can be detected, also cases where negative can be detected. Lots of information are needed/assumed in those cases.

The key word is "assume" in all these situations. We were just looking for "different or not" as the primary measure. Once we had that answer, we attempted to answer the +/- question. All answers were 100% dependent on the assumptions we used. While we could statistically verify the outcome of our assumptions, this didn't prove our assumptions to be true.

Smart bio investors make this mistake more than any other, IMO. they forget all that pretty biostatistical math is 100% dependent on the assumptions they plugged in. It is very, very rare when doing biostatistical models of trial data can get you an answer that is better than your model. That's not to say modeling can't inform your risk assessment. It can and often does.

It just rarely, if ever, provides you an answer whether the trial is positive or negative.

David